Main info

Identificatie:

HOVON 75 MCL

Sponsor:

HOVON

Working group party:

Lymphoma

Age:

18-65

Stadium:

1st lijn

Echelon:

Level C-SCT

Included patients:

140

(of 135)

Active sites:

16

(of 16)

Title:

Bortezomib maintenance therapy in newly diagnosed patients with mantle cell lymphoma, responsive on rituximab combined with CHOP and high dose Ara-C and after BEAM with auto PSCT rescue.

Timeline

News

Flow

Details

Phase:

Prospective randomized Phase II study

Monitoring Type:

Study Specific

Objectives:

Primary objective
To study the efficacy and safety of bortezomib maintenance after induction with HD Ara-C and stem cell transplantation.

Secondary objective
To study the value of FDG-PET, flow cytometry and IGVH–PCR for defining the quality of remission after induction with high dose chemotherapy and Rituximab, after auto PSCT and during maintenance treatment with bortezomib, in comparison to conventional definitions.

Eligibility

Inclusion Criteria:

Patients with histologically and immunologically proven diagnosis of MCL (WHO classification)

• Ann Arbor stage II – IV
• CD20 positive
• Age 18 – 65 years (inclusive)
• WHO performance ≤ 2
• Measurable disease (also patients with isolated bone marrow disease are accepted) (appendix B)
• Written informed consent

Inclusion criteria for late randomization

• Completed BEAM treatment
• No progressive disease or relapse
• Neutrophils >0.5 x 10^9/l
• Platelets > 80 x 10^9/l

Exclusion Criteria:

• Renal failure (creatinine clearance < 50 ml/min)
• Known hypersensitivity to murine antibodies, boron or mannitol
• Any other organ dysfunction or failure that may present a risk to the patient during any phase of protocol treatment.
• Presence of CNS involvement by NHL
• Known HIV and hepatitis B or C seropositivity
• Pregnancy or lactation
• Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of (potential) organ dysfunction by localized lymphoma mass or infiltration
• Other active malignancy (less than 5 years in complete remission) except skin (nonmelanoma) or cervix carcinoma stage 1
• Active systemic infection requiring treatment
• Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
• Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis.
• Serious medical condition (such as severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease, systemic infections etc) or psychiatric illness likely to interfere with participation in this clinical study).

Exclusion criteria for late randomization

• Known hypersensitivity to murine antibodies, boron or mannitol
• Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
• Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis.
• Serious medical condition (such as severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease, systemic infections etc) or psychiatric illness likely to interfere with participation in this clinical study).

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals